Liraglutide for HIV-associated Neurocognitive Disorder

Temple University

Status and phase

Terminated

Phase 4

Conditions

Overweight

Diabetes Mellitus Type 2

HIV Infection

Obesity

Metabolic Syndrome

Treatments

Drug: Liraglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT02743598

23284

Details and patient eligibility

About

This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

Full description

HIV, insulin resistance and type 2 diabetes mellitus (DM) are independently associated with cognitive impairment. Considering the synergistic effects of HIV and DM on cognition, these subjects are at increased risk of cognitive impairment. glucagon-like peptide 1 (GLP-1) receptors have wide tissue distribution including the central nervous system. The study hypothesis is that GLP-1 could potentially ameliorate the impairments in cognition in this population. This study will assess the impact of liraglutide on neurocognitive performance and peripheral inflammatory markers. It will also evaluate the effects of liraglutide on glycemic control and metabolic risk factors in HIV infected subjects with type 2 diabetes.

Enrollment

4 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV controlled on therapy for at least 12 weeks
Viral load < 200 copies
BMI >27 to 45
Diagnosis of DM type 2 with A1-C >7 to 15
Participants must be willing to comply with all study related procedures

Exclusion criteria

Personal or family history of pancreatitis
Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
Gastroparesis
Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue
Weight loss drugs other than metformin
Type 1 diabetes mellitus or diabetic ketoacidosis
Known major cognitive deficit dementia, history of head trauma with loss of consciousness >30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection
Renal insufficiency defined as creatinine clearance < 60 mL/min
Active opportunistic infections
Pregnancy or breastfeeding
Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome
Decompensated heart failure
Substance abuse
Active alcohol or opioid substitution therapy
Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation